Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55313 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 12, 2006. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.511 is amended by 

alphabetically revising commodities and 

adding cotton seed to the table in 

paragraph (a) to read as follows: 

§ 180.511 Buprofezin; tolerance for 

residues 

(a) *** 

Commodity Parts per million Expiration/revocation 

dates 

*****

Almond hulls ...................................................................................................................................... 2.0 None 

*****

Cotton, gin byproducts ....................................................................................................................... 20.0 None 

Cotton seed ....................................................................................................................................... 0.35 None 

*****

Tomato ............................................................................................................................................... 0.40 None 

*****

* * * * * 

[FR Doc. 06–8065 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0299; FRL–8093–8] 

Trifloxystrobin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

Trifoxystrobin (Benzeneacetic acid, 

(E,E)-a-(methoxyimino)-2-[[[[1-[3- 

(trifluoromethyl) 

phenyl]ethylidene]amino]oxy]methyl]-, 

methyl ester and the free form of its acid 

metabolite CGA-321113 ((E,E)- 

methoxyimino-(2-[1-(3- 

trifluoromethylphenyl) 

ethylideneaminooxymethyl] 

phenyl)acetic acid)) in or on soybean, 

forage at 10.0 parts per million (ppm), 

soybean, hay at 25.0 ppm, and soybean, 

seed at 0.08 ppm. Bayer CropScience 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 22, 2006. Objections and 

requests for hearings must be received 

on or before November 21, 2006, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2005–0299. All documents in the 

docket are listed in the index for the 

docket. Although listed in the index, 

some information is not publicly 


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55314 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S-4400, 

One Potomac Yard (South Building), 

2777 S. Crystal Drive, Arlington, VA. 

The Docket Facility is open from 8:30 

a.m. to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Janet Whitehurst, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6129; e-mail address: 

janet.whitehurst@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2005–0299 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 21, 2006. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2005–0299, by one of 

the following methods: 

• Federal eRulemaking Portal http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S-4400, One 

Potomac Yard (South Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket telephone number is (703) 305–

5805. 

II. Background and Statutory Findings 

In the Federal Register of January 4, 

2006 (71 FR 340) (FRL–7750–6), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 5F6956) by Bayer 

CropScience, P.O. Box 12014, 2 T.W. 

Alexander Drive, Research Triangle 

Park, NC 27709. The petition requested 

that 40 CFR 180.555 be amended by 

establishing tolerances for combined 

residues of the fungicide trifloxystrobin, 

(Benzeneacetic acid, (E,E)-a- 

(methoxyimino)-2-[[[[1-[3- 

(trifluoromethyl) 

phenyl]ethylidene]amino]oxy]methyl]-, 

methyl ester and the free form of its acid 

metabolite CGA-321113 ((E,E)- 

methoxyimino-(2-[1-(3- 

trifluoromethylphenyl) 

ethylideneaminooxymethyl)phenyl) 

acetic acid)) in or on soybean, forage at 

8.0 ppm, soybean, hay at 20.0 ppm, and 

soybean, seed at 0.08 ppm. That notice 

included a summary of the petition 

prepared by BayerCropScience, the 

registrant. The petition also proposed a 

4.2 ppm tolerance for aspirated grain 

fractions (AGF) derived from soybean 

seed. However, this tolerance is not 

necessary as residues in/on soybean 

AGF are covered by the existing 5.0 

ppm tolerance or AGF, which was 

established in conjunction with the use 

of trifloxystrobin on wheat. There were 

no comments received in response to 

the notice of filing. 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 


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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55315 

aggregate exposure to the pesticide 

chemical residue. . . .’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see: 

http://www.epa.gov/fedrgstr/EPAPEST/1997/November/Day-26/ 

p30948.htm 

http://www.epa.gov/oppfead1/trac/ 

science 

http://www.epa.gov/pesticides/ 

factsheets/ riskassess.htm 

http://www.epa.gov/pesticides/trac/ 

science/ aggregate.pdf. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for combined 

residues of trifloxystrobin and CGA 

321113 on soybean, forage at 10.0 ppm, 

soybean, hay at 25.0 ppm, and soybean, 

seed at 0.08 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing the tolerance follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

trifloxystrobin as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found in the Federal Register of 

March 29, 2006 (71 FR 15597) (FRL–

7759–9). 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which the NOAEL from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the LOAEL 

of concern identified is sometimes used 

for risk assessment if no NOAEL was 

achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

characterization at either of the 

following websites: 

http://www.epa.gov/pesticides/ 

factsheets/riskassess. htm; 

http://www.epa.gov/oppfead1/trac/ 

science. 

A summary of the toxicological 

endpoints for trifloxystrobin human risk 

assessment is shown in the following 

Table 1: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF 

FQPA SF and Level of 

Concern for Risk Assessment Study and Toxicological Effects 

Acute dietary (female 13-49 

only) 

NOAEL = 250 mg/kg/day 

UF = 100 

Acute RfD = 2.5 mg/kg/day 

FQPA SF = 1X 

aPAD = aRfD 

FQPA SF= 2.5 mg/kg/day 

Developmental toxicity - rat 

LOAEL = 500 mg/kg/day, based upon increased fetal skeletal anomalies. 

Acute dietary General Population including infants and children. There were no appropriate toxicological effects attributable to a single exposure (dose) observed in oral toxicity studies including maternal effects in developmental studies in rats and rabbits. Therefore, a dose and endpoint were not identified for this risk assessment. 

Chronic dietary (all populations) Parental NOAEL= 3.8 mg/ 

kg/day 

UF = 100 

Chronic RfD = 0.038 mg/ 

kg/day 

FQPA SF = 1X 

cPAD = cRfD 

FQPA SF= 0.038 mg/kg/ 

day 

Two-generation reproduction study - rat 

LOAEL = 55.3 mg/kg/day, based upon decreases in body weight, body weight gains, 

reduced food consumption and 

histopathological lesions in the liver, kidneys 

and spleen. 

Short-term (1-30 days) and 

intermed-term (1-6 months) 

oral 

Offspring NOAEL= 3.8 mg/ 

kg/day 

LOC for MOE = 100 (residential, includes the 

FQPA SF) 

Two-Generation reproduction study - rat 

LOAEL = 55.3 mg/kg/day, based upon reduced 

pup body weights during lactation 

Short-term (1-30 days) and 

intermed-term (1-6 months) 

dermal 

Dermal study NOAEL = 

100 mg/kg/day 

LOC for MOE = 100 (occupational) 

LOC for MOE = 100 (residential, includes the 

FQPA SF) 

28-Day dermal toxicity study - rat 

LOAEL = 1,000 mg/kg/day, based upon increases in mean absolute and relative liver 

and kidney weights 

Long-term dermal (>6 months) Oral study NOAEL= 3.8 

mg/kg/day (dermal absorption rate = 33%) 

LOC for MOE = 100 (occupational) 

LOC for MOE = 100 (residential, includes the 

FQPA SF) 

Two-generation reproduction study - rat 

LOAEL = 55.3 mg/kg/day, based upon decreases in body weight, body weight gains, 

reduced food consumption and 

histopathological lesions in the liver, kidneys 

and spleen 


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55316 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FOR USE IN HUMAN RISK ASSESSMENT—Continued 

Exposure Scenario Dose Used in Risk Assessment, UF 

FQPA SF and Level of 

Concern for Risk Assessment Study and Toxicological Effects 

Short-term (1-30 days), 

intermed-term (1-6 months) 

and long-term >6 months) inhalation 

Oral study NOAEL= 3.8 

mg/kg/day 

(Inhalation absorption rate 

= 100%) 

LOC for MOE = 100 (occupational) 

LOC for MOE = 100 (residential, includes the 

FQPA SF) 

Two-generation reproduction study - rat 

LOAEL = 55.3 mg/kg/day, based upon decreases in body weight, body weight gains, 

reduced food consumption and 

histopathological lesions in the liver, kidneys 

and spleen 

Cancer (oral, dermal, inhalation) Trifloxystrobin is classified as ‘‘Not Likely Human Carcinogen’’ based on the lack of evidence of carcinogenicity in mouse and rat cancer studies 

1 UF = uncertainty factor, FQPA SF = Special FQPA SF, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect 

level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.555) for the 

combined residues of trifloxystrobin 

and CGA 321113 in or on a variety of 

raw agricultural commodities. Risk 

assessments were conducted by EPA to 

assess dietary exposures from 

trifloxystrobin in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

In conducting the acute dietary 

exposure assessment EPA used the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM-FCIDTM), which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII), and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the acute exposure 

assessments: The acute dietary exposure 

analysis for trifloxystrobin is a Tier 1 

assessment (assuming 100 percent crop 

treated (%CT) and tolerance level 

residues). The acute dietary endpoint 

was found to be applicable only to the 

population subgroup females 13-49 

years old. An acute dietary endpoint for 

the general population including infants 

and children was not identified. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEM-FCIDTM, which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide CSFII, 

and accumulated exposure to the 

chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: A 

conservative chronic dietary analysis for 

trifloxystrobin was conducted using 

tolerance-level residues for all 

commodities with existing and 

proposed tolerances except for meat 

byproducts of cattle, goats, horses, and 

sheep because the metabolite L7a (the 

taurine conjugate of trifloxystrobin) is 

included in the risk assessment for liver. 

For all commodities, 100% CT was 

used. 

iii. Cancer. Trifloxystrobin is 

classified as a ‘‘Not Likely Human 

Carcinogen.’’ Due to the classification, 

no cancer risk assessment was 

performed. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

trifloxystrobin in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

trifloxystrobin. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. EPA 

determined estimated drinking water 

concentrations (EDWCs) of 

trifloxystrobin using the PRZM/EXAMS, 

FIRST and SCI-GROW models. The 

highest EDWCs for surface water and 

ground water acute exposure (92 parts 

per billion (ppb)) and surface water and 

ground water chronic exposure (140 

ppb) were used in the dietary analysis. 

The chronic exposure value is higher 

than the acute exposure value due to 

some very conservative assumptions in 

the chronic assessment. These estimates 

of residues in drinking water were 

incorporated directly into the DEEMFCID model of the dietary risk 

assessment. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Trifloxystrobin is currently registered 

for use on the following residential nondietary sites: Turfgrass and ornamentals. 

The risk assessment was conducted 

using the following residential exposure 

assumptions: Trifloxystrobin is 

currently registered for residential uses 

including disease control in turfgrass 

and ornamentals. Up to three 

applications may be made in a season, 

with the shortest interval between 

applications being 5-7 days. Because 

FQPA requires consideration of 

aggregate exposure to all likely nonoccupational uses, this assessment uses 

non-occupational post-application 

contact with trifloxystrobin following 

use on turfgrass as the most common 

and worst case contributor to such 

exposures.There is potential for dermal 

(adults and children) and incidental oral 

exposure (children only) during postapplication activities. The following 

post-application exposure scenarios 

resulting from lawn treatment were 

assessed: i. Dermal exposure from 

pesticide residues on lawns, ii. 

incidental non-dietary ingestion of 

pesticide residues on lawns from handto-mouth transfer, iii. incidental nondietary ingestion of residues from 

object-to-mouth activities (pesticidetreated turfgrass), and iv. incidental 

non-dietary ingestion of soil from 

pesticide-treated residential areas. Postapplication exposures from various 

activities following lawn treatment are 

considered to be the most common and 

significant in residential settings. The 

exposure via incidental non-dietary 

ingestion involving other plant material 

may occur but is considered negligible. 

Intermediate and chronic, or long-term 

exposures are not expected. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 


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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55317 

Section 408(b)(2)(D)(v) of the FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

trifloxystrobin and any other substances 

and trifloxystrobin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that trifloxystrobin has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a margin of exposure (MOE) analysis 

or through using uncertainty (safety) 

factors in calculating a dose level that 

poses no appreciable risk to humans. In 

applying this provision, EPA either 

retains the default value of 10X when 

reliable data do not support the choice 

of a different factor, or, if reliable data 

are available, EPA uses a different 

additional safety factor value based on 

the use of traditional UFs and/or special 

FQPA safety factors, as appropriate. 

2. Conclusion. The Agency found that 

because the toxicology database are 

complete for FQPA purposes and that 

there are no residual uncertainties for 

prenatal/postnatal toxicity, the 10X 

FQPA Safety Factor (SF) can be reduced 

to 1x. The FQPA SF is reduced to 1X 

because: 

• There is no indication of increased 

susceptibility of rat or rabbits to 

trifloxystrobin. In the developmental 

and reproduction toxicity studies, 

effects in the fetuses/offspring were 

observed only at or above treatment 

levels which resulted in evidence of 

parental toxicity; 

• The EPA determined that a 

developmental neurotoxicity study in 

rats is not required; 

• The acute and chronic dietary food 

exposure assessments utilize existing 

and proposed tolerance level residues 

and 100% CT information for all 

commodities. By using these screeninglevel assessments, actual exposures/ 

risks will not be underestimated; 

• The exposure assessments will not 

underestimate the potential dietary 

(food and drinking water) or non-dietary 

exposures for infants and children from 

the use of trifloxystrobin; 

• The dietary drinking water 

assessment utilizes water concentration 

values generated by model and 

associated modeling parameters, which 

are designed to provide conservative, 

health protective, high-end estimates of 

water concentrations, which are not 

likely to be exceeded; and 

• The residential postapplication 

assessment is based upon using 

residential standard operating 

procedures (SOPs). The assessment is 

based upon surrogate study data. These 

data are reliable and are not expected to 

underestimate risk to adults or children. 

The residential SOPs are based upon 

reasonable ‘‘worst-case’’ assumptions 

and are not expected to underestimate 

risk. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. The aggregate acute risk 

estimates include exposure to residues 

of trifloxystrobin in food and drinking 

water, and does not include dermal, 

inhalation or incidental oral exposure. 

Since the dietary exposure assessment 

already includes the highest acute 

exposure from the drinking water 

modeling data, no further calculations 

are necessary. The food and drinking 

water exposure estimates for females 13- 

49 years old is <1% acute population 

adjusted dose (aPAD). The acute risk 

estimate for females 13-49 years, 

resulting from aggregate exposure to 

trifloxystrobin in food and drinking 

water is below EPA’s level of concern. 

2. Chronic risk. The aggregate chronic 

risk assessment takes into account 

average exposure estimates from dietary 

consumption of trifloxystrobin (food 

and drinking water) and residential 

uses. Since the exposure from turf is 

considered short-term, the aggregate 

chronic assessment included food and 

drinking water only. Since the dietary 

exposure assessment already includes 

the highest chronic exposure from the 

drinking water modeling data, no 

further calculations are necessary. The 

general U.S. population and all 

population subgroups have exposure 

and risk estimates which are below 

EPA’s level of concern (i.e., the 

percentages of the (cPADs are all below 

100%). The exposure to the U.S. 

population was 21% of the cPAD and 

the most highly exposed subgroup, 

cildren 1-2 years old, was at 62% of the 

cPAD. Therefore, chronic risk estimates 

resulting from aggregate exposure to 

trifloxystrobin in food and drinking 

water are below EPA’s level of concern 

from all population subgroups. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). The 

short-term aggregate risk assessment 

estimates risks likely to result from 1–

30 day exposure to trifloxystrobin 

residues from food, drinking water, and 

residential pesticide uses. High-end 

estimates of residential exposure are 

used in the short-term assessment, 

while average values are used for food 

and drinking water exposure (i.e. 

chronic exposures). 

Different endpoints were identified by 

EPA for short-term incidental oral and 

dermal risk assessment (the basis for the 

oral endpoint is reduced pup body 

weights and the dermal endpoint is 

based on increases in liver and kidney 

weights). Therefore, it is not reasonable, 

as a toxicological matter, to combine 

dietary/incidental oral exposure with 

dermal exposure. A short-term aggregate 

risk assessment for dietary plus 

incidental oral exposure is needed for 

toddlers because there are residential 

postapplication incidental oral exposure 

scenarios. Toddlers’ incidental oral 

exposure is assumed to include hand-tomouth exposure, object-to-mouth 

exposure and exposure through 

incidental ingestion of soil. Because 

toddlers also have post-application 

dermal exposure as a result of the 

residential use and because it is not 

scientifically appropriate to combine 

oral and dermal exposures for 

trifloxystrobin, a separate short-term 

aggregate risk assessment is needed for 

toddlers to assess the risk of dermal 

exposure. This separate risk assessment 

only takes into account dermal exposure 

and compares this exposure to the 

dermal endpoint. The short-term 

aggregate oral exposure to all other 


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55318 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

population groups is from dietary 

exposure alone (i.e. from food and 

drinking water) because these 

population groups do not have 

incidental oral exposures. As with 

toddlers, a separate short-term aggregate 

risk assessment has been conducted for 

dermal exposure. Table 2 summarizes 

short-term aggregate risks. All shortterm aggregate risk estimates result is 

MOEs greater than 100. Therefore, EPA 

does not consider short-term aggregate 

risk to be a concern. 

TABLE 2.—SHORT-TERM AGGREGATE RISK (FOOD, DRINKING WATER AND RESIDENTIAL EXPOSURE) 

Population 

Short-Term Scenario 

NOAEL mg/ 

kg/day LOC MOE1

Average 

Food + 

Water Exposure mg/kg/ 

day 

Oral Residential Exposure2 mg/ 

kg/day 

Dermal 

Residential 

Exposure 

mg/kg/day 

Aggregate 

MOE3

U.S. population/adults oral 3.8 100 0.008145 NA NA 470 

U.S. population/adults dermal 100 100 NA NA 0.079 1300 

Youth (13-19 years old) 3.8 100 0.005969 NA NA 640 

Children (1-2 years old) oral 3.8 100 0.023704 0.00642 NA 130 

Children (1-2 years old) dermal 100 100 NA NA 0.130 770 

Females (13-49 years old) 3.8 100 0.006396 NA NA 590 

1 The LOC MOE is 100, based on inter-species and intra-species safety factors totaling 100. 

2 Oral Residential Exposure = Incidental Oral exposure from all possible sources. 

3 Aggregate MOE = NOAEL ÷ (All exposures appropriate to the assessment). 

4. Intermediate-term risk. An 

intermediate-term aggregate risk 

assessment (1 to 6 months of exposure 

to trifloxystrobin residues from food, 

drinking water, and residential pesticide 

uses) is not expected to occur based on 

the short soil half-life (about 2 days). 

Therefore, an intermediate-term 

aggregate risk assessment was not 

performed. 

5. Aggregate cancer risk for U.S. 

population. EPA determined that 

trifloxystrobin should be classified as a 

‘‘Not Likely Human Carcinogen.’’ EPA 

does not expect trifloxystrobin to pose 

a cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to 

trifloxystrobin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate Gas Liquid 

Chromatography/Nitrogen Phosphorous 

(GC/NPD) method, Method AG-659A, is 

available for enforcing tolerances for the 

combined residues of trifloxystrobin 

and the free form of its acid metabolite 

(CGA-321113) in plant and livestock 

commodities. This method was 

validated by the and forwarded to FDA 

for inclusion in PAM Vol. II. 

In the current soybean field trials and 

processing study, residues of 

trifloxystrobin and CGA-321113 were 

determined using a LC/MS/MS method 

(Bayer Report No. 200177), which was 

previously developed for the analysis of 

residues in tomatoes and peppers. This 

method uses the same extraction 

procedures as the current tolerance 

enforcement method, but uses different 

clean up procedures and detection by 

LC/MS/MS. This method is adequate for 

collecting residue data on 

trifloxystrobin and CGA-321113 in 

soybean commodities. 

B. International Residue Limits 

There are currently no Codex, 

Canadian, or Mexican MRL’s or 

tolerances for trifloxystrobin on 

soybeans. Therefore, international 

harmonization is not an issue for this 

petition. 

V. Conclusion 

Therefore, the tolerance is established 

for combined residues of trifoxystrobin, 

(Benzeneacetic acid, (E,E)-a- 

(methoxyimino)-2-[[[[1-[3- 

(trifluoromethyl) phenyl] ethylidene] 

amino]oxy]methyl]-, methyl ester and 

the free form of its acid metabolite CGA321113 ((E,E)-methoxyimino-(2-[1-(3- 

trifluoromethylphenyl) 

ethylideneaminooxymethyl)phenyl) 

acetic acid)) in or on soybean, forage at 

10.0 ppm, soybean, hay at 25.0 ppm, 

and soybean, seed at 0.08 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 


rwilkins on PROD1PC63 with RULES_1
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55319 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 14, 2006. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.555 is amended by 

alphabetically adding commodities to 

the table in paragraph (a) to read as 

follows: 

§ 180.555 Trifloxystrobin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

*****

Soybean, forage ....................... 10.0 

Soybean, hay ............................ 25.0 

Soybean, seed .......................... 0.08 

*****

* * * * * 

[FR Doc. 06–8060 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[Docket ID No. EPA–HQ–SFUND–1994–

0009; FRL–8221–6] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct Final Notice of Deletion 

of the Army Materials Technology 

Laboratory Superfund Site from the 

National Priorities List. 

SUMMARY: EPA Region 1 is publishing a 

direct final notice of deletion of the 

Army Materials Technology Laboratory 

Superfund Site (Site), located in 

Watertown, Massachusetts, from the 

National Priorities List (NPL). The NPL, 

promulgated pursuant to section 105 of 

the Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) of 1980, as amended, is 

Appendix B of 40 CFR part 300, which 

is the National Oil and Hazardous 

Substances Pollution Contingency Plan 

(NCP). EPA is publishing this direct 

final notice of deletion with the 

concurrence of the Commonwealth of 

Massachusetts, through the Department 

of Environmental Protection (MADEP), 

because EPA determined that all 

appropriate response actions under 

CERCLA—other than operation and 

maintenance and five-year reviews—

have been completed and further 

remedial action pursuant to CERCLA is 

not appropriate. 

DATES: This direct final deletion will be 

effective November 21, 2006 unless EPA 

receives adverse comments by October 

23, 2006. If adverse comments are 

received, EPA will publish a timely 

withdrawal of the direct final deletion 

in the Federal Register informing the 

public that the deletion will not take 

effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ–

SFUND–1994–0009, by one of the 

following methods: 

• www.regulations.gov: Follow the 

on-line instruction for submitting 

comments. 

• E-mail: keckler.kymberlee@epa.gov. 

• Fax: (617) 918–0385. 

• Mail: Kymberlee Keckler, Remedial 

Project Manager, U.S. Environmental 

Protection Agency, Region 1, 1 Congress 

Street, Suite 1100 (HBT), Boston, 

Massachusetts 02114–2023. 

• Hand delivery: 1 Congress Street, 

Suite 1100 (HBT), Boston, 


rwilkins on PROD1PC63 with RULES_1